Saturday, December 22, 2012

Over the past year, biopharmaceutical
researchers' work has continued to yield innovative treatments to
improve the lives of patients. In fiscal year (FY) 2012 (October 1, 2011
– September 30, 2012), the U.S. Food and Drug Administration (FDA)
approved 35 new medicines, keeping pace with the previous fiscal year’s
approvals and representing one of the highest levels of FDA approvals in
recent years.[i]For the calendar year FDA is on track to approve more new medicines than any year since 2004.[ii]

A recent report
from the FDA highlights the groundbreaking medicines to treat diseases
ranging from the very common to the most rare. Some are the first
treatment option available for a condition, others improve care for
treatable diseases.

Notable approvals in FY 2012 include:

A breakthrough personalized medicine for a rare form of cystic fibrosis;

The first approved human cord blood product;

A total of ten drugs to treat cancer, including the first
treatments for advanced basal cell carcinoma and myelofibrosis and a
targeted therapy for HER2-positive metastatic breast cancer;

Nine treatments for rare diseases; and

Important new therapies for HIV, macular degeneration, and meningitis.

The number of new drugs approved this year reflects the continuing
commitment of the biomedical research community – from biopharmaceutical
companies to academia to government researchers to patient groups –
to advance basic science and translate that knowledge into novel
treatments that will advance our understanding of disease and improve
patient outcomes.

Building on these noteworthy approvals, we look to the new year where
continued innovation is needed to leverage our growing understanding of
the underpinnings of human disease and to harness the power of
scientific research tools to discover and develop new medicines.